Parkinson DiseaseNCT06476912
Balance Exercise and Vagus Nerve Stimulation on Weight-shifting Control and Ambulation in Parkinson Disease and Anxiety
A study testing weight-shifting exercise in people with Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Postural balance and anxiety are the two critical factors for reducing independence and quality of life in patients with Parkinson's disease (PD). Anxiety would deteriorate balance and gait dysfunction. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- weight-shifting exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Sep 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopathic Parkinson's disease
- Parkinson Anxiety Scale < 13 scores: non-anxiety group or PAS >14 scores: anxiety group
- subject can walk for 20 meters without assistance
- no other neurological disease
Who cannot join
- Mini-Mental State Examination, MMSE < 26 scores
- depression
- brain surgery such as deep brain stimulation
- people with visual impairments
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
School and graduate institute of physical therapy
Taipei
Cheng-Ya Huang, PhD, 886-2-33668131
About this study
Official title: Investigating the Effects of Combined Balance Exercise and Vagus Nerve Stimulation on Weight-shifting Control and Ambulation in Patients With Parkinson Disease and Anxiety: Under Time and Space Constraints
Postural balance and anxiety are the two critical factors for reducing independence and quality of life in patients with Parkinson's disease (PD). Anxiety would deteriorate balance and gait dysfunction. Especially, relative to non-constraint condition, PD patients with anxiety had greater increases in anxiety level and balance/gait impairment in time-constraint or space-constraint condition than PD patients without anxiety. Presently, the appropriate managements for reducing anxiety in patients with PD had not been comprehensively investigated. Vagus nerve stimulation (VNS) is one kind intervention of neuromodulation. Previous studies showed that VNS could reduce anxiety level for patients with anxiety syndrome. In addition, motor training with VNS could reinforce training benefits due to facilitation of brain plasticity. However, there is no study investigating the effect of VNS on anxiety in PD. Also, the effect of combined exercise training and VNS on balance and gait in PD has not been studied. With the use of behavior performance, skin conductance response, and electroencephalogram (EEG) measurement, the purpose of the 3-year research project is to investigate the effects of VNS on anxiety and balance/gait control in patients with PD. In the first year, we will investigate the immediate effect of VNS on anxiety and weight-shifting performance in conditions with time constraint and space constraint. In the second and third years, we will the investigate long-term effects of combined exercise training and VNS on anxiety level, weight-shifting and walking performance in time constraint condition and space constraint condition, respectively. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of anxiety and balance control with VNS, but to optimize rehabilitation strategy for PD patients with anxiety.
Read the detailed description
Anxiety is one of the most prevalent psychiatric comorbidities in patients with Parkinson disease (PD) and would deteriorate patients' motor symptom and quality of life. In particular, under space constraint condition, the increased anxiety level would impair balance control and ambulation in PD. Current pharmacological management and non-pharmacological management for reducing anxiety lack of significant efficacy. Vagus nerve stimulation (VNS) is a neurostimulation intervention for anxiety, and transcutaneous vagus nerve stimulation (tVNS) can be undergone with a transcutaneous electrical nerve stimulator, which is an accessible tool in clinic. However, there is no study investigating tVNS effects on anxiety reduction in PD. Therefore, the purpose of this study is to investigate the effect of combined balance training and tVNS on reducing anxiety and improving balance and gait in patients with PD, especially under space constraint condition.
- Conditions
- Parkinson Disease
- Being tested
- weight-shifting exercise
- Keywords
- Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight-shifting exerciseOther
Also called vagus nerve stimulation
lateral weight-shifting balance training and VNS
| Study group | Role | What they receive |
|---|---|---|
| active VNS | Experimental | active vagus nerve stimulation Receives: Other: weight-shifting exercise |
| sham VNS | Sham comparator | sham vagus nerve stimulation Receives: Other: weight-shifting exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG relative power
brain excitability
Measured: 10 minutes
Secondary outcomes (2)
Weight-shifting tracking error
behavior performance
Measured: 10 minutes
Skin conductance level
sweat gland activation
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start13 Sep 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Ya Huang, PhD, Study director, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476912
- Sponsor's protocol ID
- 202301082RIND
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to concerns about participant privacy and confidentiality. Although the data will be de-identified, we prioritize the protection of our participants' personal information.
Publications
Hung YT, Wu RM, Huang CY. Effects of transcutaneous vagus nerve stimulation on anxiety and balance under space constraints in Parkinson's disease with anxiety syndrome: A preliminary study. J Parkinsons Dis. 2026 Jul 7:1877718X261465238. doi: 10.1177/1877718X261465238. Online ahead of print.
PubMed 42412060
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Combined Balance Exercise and Vagus Nerve Stimulation on Weight-shifting Control and Ambulation in Patients With Parkinson Disease and Anxiety: Under Time and Space Constraints
- ClinicalTrials.gov ID
- NCT06476912
- Acronym / sponsor ID
- 202301082RIND
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postural balance and anxiety are the two critical factors for reducing independence and quality of life in patients with Parkinson's disease (PD). Anxiety would deteriorate balance and gait dysfunction. Especially, relative to non-constraint condition, PD patients with anxiety had greater increases in anxiety level and balance/gait impairment in time-constraint or space-constraint condition than PD patients without anxiety. Presently, the appropriate managements for reducing anxiety in patients with PD had not been comprehensively investigated. Vagus nerve stimulation (VNS) is one kind intervention of neuromodulation. Previous studies showed that VNS could reduce anxiety level for patients with anxiety syndrome. In addition, motor training with VNS could reinforce training benefits due to facilitation of brain plasticity. However, there is no study investigating the effect of VNS on anxiety in PD. Also, the effect of combined exercise training and VNS on balance and gait in PD has not been studied. With the use of behavior performance, skin conductance response, and electroencephalogram (EEG) measurement, the purpose of the 3-year research project is to investigate the effects of VNS on anxiety and balance/gait control in patients with PD. In the first year, we will investigate the immediate effect of VNS on anxiety and weight-shifting performance in conditions with time constraint and space constraint. In the second and third years, we will the investigate long-term effects of combined exercise training and VNS on anxiety level, weight-shifting and walking performance in time constraint condition and space constraint condition, respectively. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of anxiety and balance control with VNS, but to optimize rehabilitation strategy for PD patients with anxiety.
Detailed description
Anxiety is one of the most prevalent psychiatric comorbidities in patients with Parkinson disease (PD) and would deteriorate patients' motor symptom and quality of life. In particular, under space constraint condition, the increased anxiety level would impair balance control and ambulation in PD. Current pharmacological management and non-pharmacological management for reducing anxiety lack of significant efficacy. Vagus nerve stimulation (VNS) is a neurostimulation intervention for anxiety, and transcutaneous vagus nerve stimulation (tVNS) can be undergone with a transcutaneous electrical nerve stimulator, which is an accessible tool in clinic. However, there is no study investigating tVNS effects on anxiety reduction in PD. Therefore, the purpose of this study is to investigate the effect of combined balance training and tVNS on reducing anxiety and improving balance and gait in patients with PD, especially under space constraint condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active VNS | Experimental | Other: weight-shifting exerciseactive vagus nerve stimulation |
| sham VNS | Sham comparator | Other: weight-shifting exercisesham vagus nerve stimulation |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- idiopathic Parkinson's disease
- Parkinson Anxiety Scale < 13 scores: non-anxiety group or PAS >14 scores: anxiety group
- subject can walk for 20 meters without assistance
- no other neurological disease
Key exclusion criteria (4 listed)
- Mini-Mental State Examination, MMSE < 26 scores
- depression
- brain surgery such as deep brain stimulation
- people with visual impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weight-shifting exerciseAlso: vagus nerve stimulationlateral weight-shifting balance training and VNS | Other | active VNS, sham VNS |
Primary outcome
EEG relative power
Time frame: 10 minutes
brain excitability
2 secondary outcomes
Weight-shifting tracking error
Time frame: 10 minutes
Skin conductance level
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 42412060Hung YT, Wu RM, Huang CY. Effects of transcutaneous vagus nerve stimulation on anxiety and balance under space constraints in Parkinson's disease with anxiety syndrome: A preliminary study. J Parkinsons Dis. 2026 Jul 7:1877718X261465238. doi: 10.1177/1877718X261465238. Online ahead of print.
- Individual participant dataSharing planned: No. IPD will not be shared due to concerns about participant privacy and confidentiality. Although the data will be de-identified, we prioritize the protection of our participants' personal information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Ya Huang, PhD study director
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight-shifting exercise in people with Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Ya Huang, PhD (886-2-3366-8131, rcyhuang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG relative power (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06476912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.